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Few topics generate as much interest as the reduction of drug manufacturing end-of-line rejects, which is one of the clearest and easiest ways to reduce waste and maximize operating profit and may help improve patient safety. One of the largest contributing factors to the end-of-line reject rate is the quality of the packaging components selected for the drug product.
The manufacturing process for packaging components is not perfect, and pharmaceutical manufacturers understand that there will be a small number of defects and embedded and loose particles in each component lot. Typically, these defects fall well within the component manufacturers’ acceptable quality level (AQL) specification, but industry requirements may be tighter.
Incoming inspection processes, while necessary, will not reduce end-of-line rejects. Incoming inspection merely confirms the component manufacturing process produced its intended product with its intended specification, but it obviously does not change the component manufacturing process. Even 100 percent vision inspection is not a complete solution because quality cannot be inspected into a component.
True end-of-line reject reduction comes from a well-understood component manufacturing process that sets control strategies around critical process parameters, monitoring processes and trending data to ensure components are manufactured within a control space. This builds quality into the manufacturing process and ultimately reduces defects and particulate, providing a tighter specification that can be directly translated into reduced filled drug product rejects.
West has developed the NovaPure® stopper and plunger product line around these principles, providing a tighter particulate specification – including subvisible particulate, dimensional CpK data, and a tighter defect specification provided in both AQL and PPM, which directly translates to the end of the drug product filling line. When a filled drug product reject can cost hundreds of dollars, improved component quality can make a marked difference in operating profit.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
<p><span>The overall quality of a final drug product depends on the components of its packaging and delivery systems. The use of visually inspected components reduces the risk of defective components and helps ensure patient safety.</span></p>
Subvisible particulates (defined as those in the 0.1-10 micron range) are a growing concern for injectable drug manufacturers. The particles may cause aggregation, which can impact the drug product and create a potential safety risk for the patient. To help ensure product quality, the U.S. Food and Drug Administration recommends that manufacturers gain a better understanding of how subvisible particles impact the drug.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
<em>Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components</em><br />The visual inspection of injectable drug product has been a regulatory requirement since 1936<sup>1</sup>, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero<sup>2</sup>. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.<sup>3</sup> Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”<sup>4</sup>
Final packaging is often the last process step before a product leaves a factory. Any failure in the process at this point puts the cost of the finished and filled drug at risk, as well as the capacity of the process.<br />
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